Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965076
Status:
RECRUITING
Last Update Posted:
2023-07-28
First Post:
2023-07-06
Brief Title:
Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM
Sponsor:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Organization:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Study Overview
Official Title:
Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM a Factorial Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims at comparing different procedures of Professional Oral Hygiene POH and Domiciliary Oral Hygiene DOH in Columbus Bridge ProtocolTM full-arch reinstated patients by dividing a sample of at least 74 patients into 4 groups with a 1111 ratio The patients will randomly be assigned to a Standard or Glycine Perio Flow Professional treatment and to a Standard or Angled Toothbrush for their Domiciliary oral hygiene
Data about bacterial plaque presence is collected both before and after unscrewing the denture when it comes to implant abutments Instead Denture Plaque Index will be collected after unscrewing the denture by means of erythrosine and analyzed using a specific software that allows to compute the percentage of plaque on the denture
Patients will be seen after 3 months in order to figure out differences between DOH groups by measuring plaque on abutments and on the denture after unscrewing it
At the moment there are no scientific studies trying to determine which professional and domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge ProtocolTM reinstated patients
Statistically significant lower Plaque Index PI and Denture Plaque Index DPI scores are expected in patients treated with glycine perio flow compared to standard treated patients However when it comes to angled toothbrush lower PI and DPI are expected not to be statistically significant
Expectation from this study is to get information on how to improve full-arch patients therapy in order to reduce peri-implant diseases which are related to bacterial plaque
Data about bacterial plaque presence is collected both before and after unscrewing the denture when it comes to implant abutments Instead Denture Plaque Index will be collected after unscrewing the denture by means of erythrosine and analyzed using a specific software that allows to compute the percentage of plaque on the denture
Patients will be seen after 3 months in order to figure out differences between DOH groups by measuring plaque on abutments and on the denture after unscrewing it
At the moment there are no scientific studies trying to determine which professional and domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge ProtocolTM reinstated patients
Statistically significant lower Plaque Index PI and Denture Plaque Index DPI scores are expected in patients treated with glycine perio flow compared to standard treated patients However when it comes to angled toothbrush lower PI and DPI are expected not to be statistically significant
Expectation from this study is to get information on how to improve full-arch patients therapy in order to reduce peri-implant diseases which are related to bacterial plaque
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None